NDA approval from NMPA CDE for Opamtistomig (LBL-024) to initiate Ph 3 trial for 1L EP-NEC
Dr. Charles Cai, Chief Medical Officer of Leads Biolabs, stated: “The Phase Ib/II data for Opamtistomig in first-line treatment of EP-NEC are encouraging. In our communications with the CDE, we have seen the regulatory agency’s strong focus on unmet clinical needs and its recognition of Opamtistomig’s clinical value. Based on the clear regulatory feedback, we are rapidly implementing the pivotal Phase III study protocol, and we look forward to validating its potential to extend patient survival through a high-quality trial, bringing this innovative therapy to EP-NEC patients as soon as possible.”
Share:
More News
“FDA clearance of the IND for ORM-1153 is an important milestone for Orum, bringing another first-in-class DAC into the clinic and extending our approach into CD123-expressing hematologic malignancies,” said Olaf Christensen, M.D., Chief Medical Officer of Orum Therapeutics. “By combining cell-selective delivery with targeted protein degradation in a single molecule,
“We are excited to expand our clinical collaboration with Roche to evaluate a second KRAS combination with potential best-in-class MTA-cooperative PRMT5 inhibitor IDE892 for pancreatic cancer patients, where there remains a high unmet medical need. IDEAYA is advancing multiple rational combination strategies for the IDE892 program, including with MAT2A inhibitor
“These encouraging initial safety observations represent an important first step in the clinical evaluation of ZI-MA4-1 and our TCR-NK platform” said Namir Hassan, Chief Executive Officer of Zelluna. “The first patient received all three planned doses, and the independent committee’s recommendation enables us to continue recruitment at the first dose
“Receiving FTD is an important milestone for ERAS-0015 and reflects the urgent need for new therapies for patients with metastatic pancreatic cancer,” said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder. “Together with the encouraging clinical activity and favorable tolerability observed to date, this FTD helps to position us